DAILIES AquaComfort Plus (nelficion A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Dailies AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 6.00 diopters (D) of astigmatism.

Dailies AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. the lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal are soft contact lenses intended for the optical correction of refractive error.

They are available in spherical, toric and multifocal designs as applicable:

Spherical lenses: DAILIES AquaComfort Plus
Aspherical lenses: DAILIES AquaComfort Plus FreshTech
Toric lenses: DAILIES AquaComfort Plus Toric
Multifocal lenses: DAILIES AquaComfort Plus Multifocal

The lens material is nelfilcon A, a high water non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water. The material further contains non-functionalized PVA (high- and or Ultra molecular weight PVA) and the color additive phthalocyanine green (CFR 73.3124).

DAILIES AquaComfort Plus products are supplied sterile. The lenses are immersed in buffered saline solution and are packaged in individual foil-blister packs as primary packaging and terminally sterilized in a validated autoclave (moist heat, steam under pressure). The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material. The lenses are supplied in strips of five foiled sealed blister packs each containing approximately 0.65 ml of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HMPC) and polyethyleneglycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.

AI/ML Overview

The provided text describes the 510(k) premarket notification for various DAILIES AquaComfort Plus contact lenses. It mainly focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies as typically seen for AI/ML-based devices.

Therefore, many of the requested categories, such as sample size for test sets, expert credentials, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document. This submission relies on non-clinical testing and similarity to predicate devices for its approval.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the format typically used for performance metrics like sensitivity, specificity, etc., for AI/ML devices. Instead, it compares the technological characteristics and performance specifications to predicate devices. The "acceptance criterion" for these parameters is essentially "Same" as the predicates or meeting established industry standards.

Element of Comparison	Predicate Devices Performance	Modified Device Performance	Acceptance Criteria (Implied)
Administrative/Regulatory
510(k) Number	K963487, K072777, K172066, K180398	To be assigned (K181454 upon clearance)	N/A
Product Name	DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal	DAILIES AquaComfort Plus FreshTech (and the others are modifications of these)	N/A
Device Classification	Class II, Daily Wear Soft (Hydrophilic) Contact Lenses	Same	Same Classification
Indications for Use
Intended Use	One-Day contact lenses for optical correction of vision. Single use, daily disposable wear. (Specifics vary by lens type - spherical, toric, multifocal)	Same	Same Indications
Technology Information
Lens Material	nelfilcon A	Same	Same Material
Water Content	69%	Same	69%
Visibility Tint	Light blue (copper phthalocyanine blue)	Same	Same Tint
Manufacturing Method	Lightstream Technology: Full mold cast	Same	Same Method
Lens Design	Spherical, Toric, Multifocal	Aspheric (for DAILIES AquaComfort Plus FreshTech), and spherical, toric, multifocal for the others	Spherical, Toric, Multifocal, Aspheric
Sterilization	Steam sterilization, validated autoclave	Same	Same Sterilization
Primary Packaging System	Foil blister pack container system; Polypropylene blister shell sealed with a polyester coated aluminum foil lidding	Same	Same Packaging System
Primary Packaging Blister Shell	Injection-molded polypropylene blister shell made from Flint Hills Resources P4C5N-046 Polypropylene or Formosa 4142T polypropylene	Same	Same Shell Material
Primary Packaging Foil Lidding	Multilayer laminate structure polyester coated aluminum foil lidding supplied by Constantia-Hueck Folien and/or Huhtamaki foil	Same	Same Lidding Material
Package Storage/Saline Solution	Phosphate-acetate buffered saline with up to 0.05% Poloxamer 108. Additionally contains PEG and HPMC	Same	Same Solution
Performance Specifications
Refractive Index	1.38 (hydrated)	Same	1.38 (hydrated)
Light Transmittance	≥ 92%T @ 610 nm	Same	≥ 92%T @ 610 nm
Oxygen Permeability (Dk)	26 x 10-11 (cm²/s) ml O₂/ml x mmHg) measured at 35°C (Fatt, edge effect corrected)	Same	26 x 10-11 Dk
Elastic Modulus	0.9 MPa	Same	0.9 MPa
Biocompatibility	Biocompatible as confirmed by appropriate biocompatibility testing	Same (confirmed by testing)	Biocompatible
Shelf-life	Up to 60 months as confirmed by shelf-life stability testing	Same (confirmed by testing)	Up to 60 months

2. Sample size used for the test set and data provenance:

Not Applicable. The submission states that due to the similarity of the modified device to the predicate device and successful non-clinical testing, clinical testing was not required to establish substantial equivalence. Therefore, there is no "test set" in terms of patient data for performance evaluation in a clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No clinical test set where "ground truth" would be established by experts was used.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

Not Applicable. This is not an AI/ML-based device. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI/ML-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. For non-clinical testing, "ground truth" is typically defined by laboratory standards and measurements for physical and chemical properties (e.g., precise measurement of water content, refractive index, sterility confirmation).

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI/ML device.

Study Proving Acceptance Criteria Met:

The study that proves the device meets the acceptance criteria is detailed under "VII. Performance Data" and "VIII. Conclusions." This is a collection of non-clinical tests and analyses rather than a single clinical study.

Biocompatibility Testing: "Test results from a series of in vitro and in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing confirm that the minor device modification does not negatively impact the safety of the devices. The modified device is non-toxic and biocompatible. All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards."
Sterilization: "Based on the similarity of the packaging materials and the successful completion of sterilization testing in accordance with FDA guidance and the applicable requirements of ISO 17665-1:2006."
Stability Testing: "Successful stability testing supports the labeled expiration date for the modified device."
Physico-chemical, dimensional, and optical properties: The document states that these were evaluated and "demonstrate that the aspheric lens design meets specifications." While specific test methods and results are not detailed in this summary, they would have been submitted to the FDA.

Conclusion:
The submission concludes that "The results of device performance testing evaluation including physico-chemical, biocompatibility, sterilization and stability and the qualification of the dimensional and optical properties demonstrate that the aspheric lens design meets specifications. The results supports the substantial equivalence of the device to the predicate device."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alcon Laboratories, Inc. Katryna Warren Global Project Regulatory Director, Vision Care 6201 South Freeway Fort Worth, TX 76134-2099

Re: K181454

Trade/Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® FreshTech, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: October 22, 2018 Received: October 23, 2018

Dear Katryna Warren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

J. Angelo Green

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Alcon Response to KDA Deireiency Letter DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181454

Device Name

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.

I. Submitter of the 510(k)

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Primary Contact Person:	Katryna WarrenGlobal Project Regulatory Director, Vision Care
Phone:	(817) 615-5076
Fax:	(817) 551-4630
Email:	Katryna.warren@alcon.com
Back up Contact Person:	Sherri LakotaHead, GRA Alcon Vision Care
Phone:	(817) 615-5472
Fax:	(817) 551-4630
Email:	Sherri.lakota@alcon.com
Date Prepared:	May 30, 2018

II. Devices Subject to this 510(k)

Trade Names:	DAILIES AquaComfort Plus, DAILIES AquaComfort PlusFreshTech, DAILIES AquaComfort Plus Toric and DAILIESAquaComfort Plus Multifocal
Common Name:	Soft Contact Lenses
Classification Name:	Soft (hydrophilic) Contact Lens
Device Classification:	Class II [21 CFR 886.5925]
Product Code:	MVN, LPL

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III. Predicate Device

The 510(k) devices are modifications of the same predicate devices currently legally commercialized devices cleared in the US under these 510(k) clearances: K963487, K072777, K172066, and K180398.

IV. Device Description

They are available in spherical, toric and multifocal designs as applicable:

Spherical lenses: DAILIES AquaComfort Plus ●
Aspherical lenses: DAILIES AquaComfort Plus FreshTech ●
o Toric lenses: DAILIES AquaComfort Plus Toric
Multifocal lenses: DAILIES AquaComfort Plus Multifocal 0

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v. Indications for Use

DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 6.00 diopters (D) of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

VI. Comparison to Technological Characteristics with the Predicate Device Table 1 summarizes the characteristics of the modified device compared to the predict devices:

Element of Comparison	Predicates Devices	Modified Device
Administrative/ Regulatory Information
510(k) Number	K963487, K072777, K172066,K180398	To be assigned
Product Name	DAILIES AquaComfort Plus,DAILIES AquaComfort PlusToric, DAILIES AquaComfortPlus Multifocal	DAILIES AquaComfort PlusFreshTech

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Device ClassificationInformation	Class II, Daily Wear Soft(Hydrophilic) Contact Lenses	Same
Indications for Use Information
Intended Use	One-Day contact lenses for theoptical correction of vision.Single use, daily disposablewear	Same
Technology Information
Lens Material	nelfilcon A	Same
Water Content	69%	Same
Visibility Tint	Light blue (copperphthalocyanine blue	Same
Manufacturing Method	Lightstream Technology: Fullmold cast	Same
Lens Design	Spherical, Toric, Multifocal	Aspheric
Sterilization	Steam sterilization, validatedautoclave	Same
Primary Packaging System inGeneral	Foil blister pack containersystem; Polypropylene blistershell sealed with a polyestercoated aluminum foil lidding	Same
Primary Packaging BlisterShell	Injection-molded polypropyleneblister shell made from FlintHills Resources P4C5N-046Polypropylene or Formosa4142T polypropylene	Same
Primary Packaging FoilLidding	Multilayer laminate structurepolyester coated aluminum foillidding supplied by Constantia-Hueck Folienand/or Huhtamaki foil	Same
Package Storage/SalineSolution	Phosphate-acetate bufferedsaline with up to 0.05%Poloxamer 108. Additionallycontains PEG and HPMC	Same
Performance SpecificationsIncluding any Testing
Refractive Index	1.38 (hydrated)	Same
Light Transmittance	≥ 92%T @ 610 nm	Same
Oxygen Permeability (Dk)	$26 x 10^{-11} (cm^2/s) ml O_2/ml x mmHg)$ measured at 35°C (Fatt,edge effect corrected)	Same
Elastic Modulus	0.9 MPa	Same
Biocompatibility	Biocompatible as confirmed byappropriate biocompatibilitytesting	Same
Shelf-life	Up to 60 months as confirmedby shelf-life stability testing	Same

In accordance with the criteria for claims of substantial equivalence in the FDA guidance Premarket Notification 510(k) Guidance Document for Daily Wear contact Lenses, May 1994,

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the information provided supports the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process.

VII. Performance Data

Performance testing was performed in accordance with the May 1994 FDA guideline, Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and applicable ISO standards for contact lenses. Performance data are provided in support of the substantial equivalence determination.

Biocompatibility Testing

Test results from a series of in vitro and in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing confirm that the minor device modification does not negatively impact the safety of the devices. The modified device is non-toxic and biocompatible. All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.

Sterilization

Based on the similarity of the packaging materials and the successful completion of sterilization testing in accordance with FDA guidance and the applicable requirements of ISO 17665-1:2006

Stability Testing

Successful stability testing supports the labeled expiration date for the modified device.

Clinical Testing

Based on the similarity of the modified device to the predicate device and successful results of nonclinical testing, clinical testing was not required to establish substantial equivalence.

VIII. Conclusions

The results of device performance testing evaluation including physico-chemical, biocompatibility, sterilization and stability and the qualification of the dimensional and optical properties demonstrate that the aspheric lens design meets specifications. The results supports the substantial equivalence of the device to the predicate device.

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.